Table 3 Serious adverse event details.

From: Results and lessons learnt from the WISTERIA phase I trial combining AZD1775 with cisplatin pre- or post-operatively in head and neck cancer

Days on Trial

Category

Event

Duration (Days)

Outcome

Group A

  100

Unrelated SAE

Mucositis

5

Resolved–with sequelae

  100

Unrelated SAE

Mucositis

3

Resolved–with sequelae

Group B

  384

Non-fatal/life-threatening SUSAR

Dysphagia

18

Resolved–no sequelae

  384

SAR

Diarrhoea

3

Resolved–no sequelae

  384

SAR

Nausea

2

Resolved–with sequelae

  370*

SAR

Febrile neutropenia

27

Resolved–no sequelae

  350

Unrelated SAE

Skin Infection

2

Resolved–no sequelae

  1. A list of all serious adverse events that occurred during the WISTERIA trial.
  2. SAE serious adverse event, SAR serious adverse reaction (i.e., drug-related), SUSAR suspected unexpected serious adverse reaction.
  3. *This SAE was also reported as a dose limiting toxicity (see Table 2).
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