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Patient details
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Patient initials*
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Week of pregnancy
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Date of birth*
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Breastfeeding? (yes/no)
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Gender*
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Profession
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Height*
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Weight*
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Drug
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Name of drug*
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If used previously, was the drug tolerated at the time?
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Prescribed for*
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Was the drug continued or read ministered after onset of ADR?
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Date drug started
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Date drug stopped
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Suspected of causing ADR (yes/no/unsure)
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Dosage
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Diagnosis
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Name*
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Type of diagnose (primary, concomitant, secondary)
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ICD-10 code*
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Diagnosis confirmed on date
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ADR
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Symptom
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Initial worsening of symptom
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Severity according to WHO-ART
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Serious or non-serious according to ICH
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If serious, why?
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Date ADR started
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Date ADR stopped
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Treatment of ADR completed? (yes/no)
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Reason for not completing treatment of ADR
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Causality
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