Table 4 Serious TEAEs assessed as at least possibly related to study druga (overall period)
Treatment at time of event | Patient | MedDRA preferred term | Intensity | Criteria | Causality | Duration (days) | Outcome | Subsequent study treatment |
|---|---|---|---|---|---|---|---|---|
First period IVIg | Patient 1 | Muscle spasms | Severe | Life threatening | Probable | 1 | Recovered/resolved | Study drug withdrawn |
Dyspnoea | Severe | Life threatening | Probable | 1 | Recovered/resolved | |||
Extension period (all IVIg) | Patient 2 | Deep vein thrombosis (TEE) | Severe | Hospitalisation and life threatening | Probable | 73 | Recovered/resolved | Study drug withdrawn |
Pulmonary embolism (TEE) | Severe | Hospitalisation and life threatening | Probable | 73 | Recovered/resolved | |||
Patient 3 | Cerebrovascular accident (TEE) | Moderate | Hospitalisation and medically important | Possible | 109 | Recovered/resolved with sequelae | Study drug withdrawn | |
Patient 4 | Pulmonary embolism (TEE) | Moderate | Hospitalisation and medically important | Possible | 14 | Recovered/resolved with sequelae | Study drug withdrawn | |
Patient 5 | Loss of consciousness | Moderate | Hospitalisation | Probable | 1 | Recovered/resolved | Dose of study drug unchanged The patient subsequently received a further five cycles of IVIg treatment and did not experience any further serious TEAEs | |
Patient 6 | Cerebral infarction (TEE) | Moderate | Hospitalisation and medically important | Possible | 99 | Recovered/resolved with sequelae | The serious TEAE occurred 12 days after the last infusion cycle of IVIg | |
Extension period (all IVIg) | Patient 7 | Hypoesthesia (TEE) | Mild | Medically important | Possible | 1 | Recovered/resolved | Dose of study drug unchanged The patient subsequently received one further cycle of IVIg treatment |