Table 1 Inclusion and exclusion criteria

Inclusion criteria

 Diagnosis of either;

  1. Definite tubal ectopic pregnancy (EP) (extra-uterine gestational sac with yolk sac and/or embryo, without cardiac activity on ultrasound scan (USS));

  or

  2. Clinical decision of probable tubal EP (extrauterine sac-like structure or inhomogeneous adnexal mass on USS with a background of sub-optimal serum human chorionic gonadotrophin (hCG) concentrations (on at least 2 different days)

 Clinical decision made for treatment of tubal EP with methotrexate (MTX)

 Able to understand all information (written and oral) presented (using an interpreter if necessary) and provide signed consent

 18–50 years of age at time of randomisation

 Pre-treatment serum hCG level of 1000–5000 IU/L (within 1 calendar day of randomisation)

 Clinically stable

 Haemoglobin between 100 and 165 g/L no more than 3 calendar days before randomisation

 Able to comply with treatment and willing to participate in follow-up

Exclusion criteria

 Pregnancy of unknown location (PUL)

 Evidence of intra-uterine pregnancy

 Breastfeeding

 Hypersensitivity to gefitinib

 EP mass on ultrasound greater than 3.5 cm (mean dimensions)

 Evidence of significant intra-abdominal bleed on USS defined by echogenic free fluid above the uterine fundus or surrounding ovary within 1 calendar day of treatment

 Significant abdominal pain, guarding/rigidity

 Clinically significant abnormal liver/renal/haematological indices noted no more than 3 calendar days before randomisation

 Galactose intolerance

 Significant dermatological disease, e.g. severe psoriasis/eczema

 Significant pulmonary disease, e.g. severe/uncontrolled asthma

 Significant gastrointestinal illness, e.g. Crohn’s disease/ulcerative colitis

 Participating in any other clinical trial of an investigational medicinal product

 Previous participation in GEM3

 Japanese ethnicity