Targeted patient safety Questionnaires

Questionnaire for Haemorrhagic Events

Case report Details: ……………………………..

Suspect Drug: ………………………………………

Source of report (v) Clinical Trial If yes complete details below

Spontaneous

Other If yes please specify ………………

Local reference number……………………………

Protocol study/ID…………………………………….

Centre ID ………………………………………………..

Patient ID ……………………………………………….

Patient Demographic Information

Initials …………………………………………………… Date of Birth (dd/mm/yyyy) ……………………………………

Haemorrhagic Events Details

Date of onset :……………………………………..

Description of event:

Event Start date Stop date

Suspect drug …………………….

Date started …………………….

Date stopped …………………..

Daily dose ……………………….

Indication for therapy ………………………………………………………………….

Did the haemorrhagic event result in withdrawal or alteration of dosing? (YES / NO)

If yes, please specify ……………………………………………….

Was the drug reintroduced (YES/ NO)

If yes did the abnormality recur (YES /NO)

In your medical judgement is there a reasonable possibility that the drug could have caused this
abnormality (YES/NO)

Current and Past Medical History:

Any prior administration history with the following drugs (if yes provide the details in the table
below)

Warfarins (coumarins) ? YES/NO

Heparin/ Other anticoagulants ? YES/NO

NSAIDS ? YES/NO

Concomitant therapy (to include all drugs given one month after haemorrhage)

Previous /Concomitant therapy details

Laboratory data, before, during and after the event (continue on other sheet if needed )
Outcome YES NO

Hospitalized

Recovery

Improvement but sequelae?

Death? Date …………………. Cause *……………

Disability?

* If post mortem report is available kindly attach the same

Investigator’s/Reporter’s signature……………………………………… Date ……………………………..

 Liver Injury Data Collection Form
Case report Details: ……………………………..

Suspect Drug: ………………………………………

Source of report (v) Clinical Trial If yes complete details below

Spontaneous

Other If yes please specify ………………

Local reference number……………………………

Protocol study/ID…………………………………….

Centre ID ………………………………………………..

Patient ID ……………………………………………….

Patient Demographic Information

Initials …………………………………………………… Date of Birth (dd/mm/yyyy) ……………………………………

Current and Past History

Liver Injury data collection form continued

Date of onset : ………./…../…….

Symptoms ? : YES / NO

Nature of symptoms :

Nature of symptoms Symptom Start date Symptom Stop Date

1. ……………………………..………….. ………………………. …………………………….

2. ……………………………..………….. ………………………. …………………………….
3. ……………………………..………….. ………………………. …………………………….
4. ……………………………..………….. ………………………. …………………………….
5. ……………………………..………….. ………………………. …………………………….
 Laboratory Data from before during and after the event:

Date Date Date Date Date

(dd/mm/yy) (dd/mm/yy) (dd/mm/yy) (dd/mm/yy) (dd/mm/yy)
*AST (N<……)
*ALT (N<……)
*GGT (N<……)
*Alk Phos (N<……)
*CPK (N<……)
Total bilirubin
Albumin
Creatinine
Urea
 Prothrombin time
WCC
Haemoglobin
Eosinophil
Neutrophil

*if any parameter is > or = 3*ULN let Cipla personnel know immediately and complete AE form if
appropriate.
Outcome YES NO

Hospitalized

Recovery

Improvement but sequelae?

Death? Date …………………. Cause *……………

Disability?

* If post mortem report is available kindly attach the same

Investigator’s/Reporter’s signature……………………………………… Date ……………………………..

Suspect drug …………………….

Date started …………………….

Date stopped …………………..

Daily dose ……………………….

Indication for therapy ………………………………………………………………….

Did the LFT result in withdrawal or alteration of dosing? (YES / NO)

If yes, please specify ……………………………………………….

Was the drug reintroduced (YES/ NO)

If yes did the abnormality recur (YES /NO)

In your medical judgement is there a reasonable possibility that the drug could have caused this
abnormality (YES/NO)
 Questionnaire for Patients with ILD
Case report Details: ……………………………..

Suspect Drug: ………………………………………

Source of report (v) Clinical Trial If yes complete details below

Spontaneous

Other If yes please specify ………………

Local reference number……………………………

Protocol study/ID…………………………………….

Centre ID ………………………………………………..

Patient ID ……………………………………………….

Patient Demographic Information

Initials …………………………………………………… Date of Birth (dd/mm/yyyy) ……………………………………

Questionnaire for Cerebrovascular Events

Suspect Drug: ………………………………………

Source of report (v) Clinical Trial If yes complete details below

Spontaneous

Other If yes please specify ………………

Local reference number……………………………

Protocol study/ID…………………………………….

Centre ID ………………………………………………..

Patient ID ……………………………………………….

Patient Demographic Information

Initials …………………………………………………… Date of Birth (dd/mm/yyyy) ……………………………………

Cerebrovascular event Details

Date of onset : ………./…../…….

Symptoms ? : YES / NO

Nature of symptoms :

Nature of symptoms Symptom Start date Symptom Stop Date

1. ……………………………..………….. ………………………. …………………………….

2. ……………………………..………….. ………………………. …………………………….
3. ……………………………..………….. ………………………. …………………………….
4. ……………………………..………….. ………………………. …………………………….
5. ……………………………..………….. ………………………. …………………………….

Suspect drug …………………….

Date started …………………….

Date stopped …………………..

Daily dose ……………………….

Indication for therapy ………………………………………………………………….

Did the LFT result in withdrawal or alteration of dosing? (YES / NO)

If yes, please specify ……………………………………………….

Was the drug reintroduced (YES/ NO)

If yes did the abnormality recur (YES /NO)

In your medical judgement is there a reasonable possibility that the drug could have caused this
abnormality (YES/NO)

Current and Past Medical History

Disorder or risk factor Current Past Onset date Please specify

(YES/NO) (YES/NO) (dd/mm/yy)
CNS tumour/Metastasis

Haemophilia or other
coagulation disorder
Thrombocytopenia

Thrombotic or
thrombocytopenic
purpura
Anticoagulation

Therapeutic thrombolysis

Polycythaemia Rubra Vera

Essential
thrombocythemia
Sickle cell disease

Paraproteinemia

Disseminated
intravascular coagulation
Renal failure

Liver failure

Hypertension

Valvular heart disease

Vascular malformation

Atrial fibrillation

Atherosclerosis

Previous
thrombotic/embolic event
Ischemic heart disease

Endocarditis

Sudden hypotension

Sudden hypotension
 Peripheral vascular
disease
Inflammatory vascular
disease
Vascular tumours

Diabetes mellitus

Sepsis

Hepatobiliary disease

Trauma

Surgical procedures

Alcohol consumption

Tobacco smoking

Any prior administration history with the following drugs? (if yes provide information in
the table below)
Warfarins (coumarins) ? YES/NO

Heparin/ Other anticoagulants ? YES/NO

Anti-Platelet drugs ? YES/NO

Hormonal therapies ? YES/NO

Concomitant therapy (to include all the drugs given within 1 month of the cerebrovascular event )

Trade name/drug Route Daily Start date Stop date Indication

Name dose
Previous /concomitant chemotherapy details

Trade name/drug Route Daily Start date Stop date Indication

Name dose

Previous /concomitant Radiotherapy details

Trade name/drug Route Daily Start date Stop date Indication

Name dose
Test Date Yes No Comments
Ultrasound
ECG
MRI
CT
Vessel biopsy
Cerebral
angiography
Other
*please attach copy of report
Outcome YES NO

Hospitalized

Recovery

Improvement but sequelae?

Death? Date …………………. Cause *……………

Disability?

* If post mortem report is available kindly attach the same

Investigator’s/Reporter’s signature……………………………………… Date ……………………………..

Targeted follow up questionnaire – Gastrointestinal Perforation

Details of Suspect Medication

Please circle the appropriate response for the question below

Was Gefitinib stopped due to gastrointestinal perforation? Yes/NO
Was Gefitinib reintroduced after the event resolved ? Yes/NO
Please provide all details of all concomitant medication taken by the patient prior to or at
the time of gastrointestinal perforation in the table below
Drug Name Indication Route Daily Start date Stop date
dose
Please indicate whether the patient’s medical history includes any of the following prior to
or at the time of gastrointestinal perforation
Please provide any further relevant information in the space provided or the sheet attached:

Print name and title of person completing form Signature of person completing form

If physician, specify speciality Date

If completed by a person in proxy for a physician, please also indicate the following

Name Job title