Table 7 Possibly and probably related adverse events leading to discontinuation of study drug (overall period)
Treatment at time of event | Patient | MedDRA preferred term | Intensity | Serious | Causality | Outcome |
|---|---|---|---|---|---|---|
First period IVIg | Patient 1 | Muscle spasms | Severe | Yes | Probable | Recovered/resolved |
Sinus tachycardia | Moderate | No | Probable | Recovered/resolved | ||
Chills | Mild | No | Probable | Recovered/resolved | ||
Fever | Mild | No | Probable | Recovered/resolved | ||
Dyspnoea | Severe | Yes | Probable | Recovered/resolved | ||
Back pain | Moderate | No | Probable | Recovered/resolved | ||
Extension period (all IVIg) | Patient 2 | Deep vein thrombosis (TEE) | Severe | Yes | Probable | Recovered/resolved |
Pulmonary embolism (TEE) | Severe | Yes | Probable | Recovered/resolved | ||
Patient 3 | Vertigo | Moderate | No | Possible | Recovered/resolved | |
Vision blurred | Mild | No | Possible | Recovered/resolved | ||
Cerebrovascular accident (TEE) | Moderate | Yes | Possible | Recovered/resolved with sequelae | ||
Patient 4 | Pulmonary embolism (TEE) | Moderate | Yes | Possible | Recovered/resolved with sequelae | |
Patient 8 | Musculoskeletal pain | Mild | No | Possible | Recovered/resolved | |
Paraesthesia | Mild | No | Possible | Recovered/resolved | ||
Dizziness | Mild | No | Possible | Recovered/resolved | ||
Condition aggravateda | Mild | No | Not related | Recovered/resolved | ||
Patient 9 | Headache | Moderate | No | Probable | Recovered/resolved | |
Nausea | Moderate | No | Probable | Recovered/resolved | ||
Patient 10 | Hypersensitivity | Mild | No | Probable | Recovered/resolved | |
Patient 11 | Vomiting | Mild | No | Probable | Recovered/resolved |