Table 1

Summary of data collection

Trial visits, investigations and interventionsBaseline
(within −15 days of
first dose)		Cycle 1
day 1
(C1, D1)		Cycle 1
day 8
(C1, D8)		Cycle 1
day 15
(C1, D15)		Cycle 1
day 22
(C1, D22)		Cycle 2
day 1
(C2, D1)		Cycle 2
day 15
(C2, D15)		Cycle 3
day 1
(C3, D1)		Cycle 3
day 15
(C3,D15)		Cycle 4
day 1
(C4, D1) onwards		End of treatment visit28-day post-treatment follow-up visitFU
Pts not progressed but withdrawn from treatment
(8 weekly*)
Day 1Day 8Day 15Day 22Day 29Day 43Day 57Day 71Day 99 onwards
4 weekly
Assessment window† - 3 days±3 days±3 days±3 days±3 days±3 days±3 days±3 days±3 days+7 days+7 days±3 days
Written informed consentX (<4 weeks)            
DemographicsX            
Medical history/baseline conditionsX            
Physical examination ‡XX X X X XX  
Clinical disease assessment‡XX X X X XX  
ECOG performance status‡XX X XXXXXXX 
Vital signs (pulse, BP)XXXXXXXXXXXX 
HeightX            
WeightX    X X X   
Body surface areaX    X X X   
Haematology inc diffs§XXXXXXXXXXXX 
Biochemistry§XXXXXXXXXXXX 
TSH/T4X      X¶ X3, 4   
CoagulationX**            
Pregnancy test if applicable
(serum or urine HCG)		X (<28 days)X   X X X   
ECGX (<8 days)            
ECHO/LVEF††X††      X†† X††   
Urine analysis‡‡X‡‡X¶   X¶ X¶ X¶   
CT/MRI scan*X (<4 weeks)      X* X*X§§ X
CA125¶¶XX   X X X¶¶X X
Quality of lifeX    X X XX  
Concomitant treatments and diary card reviewXXXXXXXXXXXX 
Adverse events10XXXXXXXXXXXXX‡‡‡
Research bloods††† X   X X  X§§  
Archival tissueX            
Arm A: IV weekly paclitaxel ‡ Paclitaxel days 1, 8 and 15 of every cycle   
Arm B: PO olaparib Continuous   
Arm C: PO cediranib +olaparib Continuous   
Survival data            X

  • *CT scan should be carried out every 8 weeks regardless of treatment delays for the first 12 months of treatment. If patients remain on treatment longer than 12 months CT scans should be carried out every 12 weeks (±7 days window for on study and follow-up scans). Scheduled on treatment scan timepoints (in weeks): 8, 16, 24, 32, 40, 48, 56, 68 and 80.

  • †Safety assessments valid up to 3 days from visit date for patients taking olaparib or the olaparib/cediranib combination. For C1D1 and for participants receiving paclitaxel must have safety assessments up to 3 days prior to dosing.

  • ‡On paclitaxel arm, assessments requiring a clinician are only required on day one of each cycle as per standard of care: physical examination, clinical disease assessment, ECOG.

  • §On the paclitaxel arm, haematology and biochemistry should be performed prior to days 1, 8 and 15 of each cycle. Haematology: Hb, WBC with differential count (neutrophils and lymphocytes) and platelets, clotting (aPTT, PT or INR).

  • ¶Arm C only.

  • **At screening for all patients, and later as clinically indicated for example, patients on anticoagulants.

  • ††ECHO at screening for patients with prior treatment/comorbidities see section 8.5.1. If patient requires ECHO at screening repeat ECHO at C3D1 and 3 monthly thereafter if randomised to Arm C only.

  • ‡‡At screening, if a patient has two consecutive dipstick urine protein measurements of greater than two plus (+) taken no less than 1 week apart then collect a 24 hours urine for total protein and ensure urinary protein is <1.0 g or protein/creatinine ratio <1.5.

  • §§At progression.

  • ¶¶CA125 on day 1 of each cycle and at end of treatment. 8 weekly for patients who have withdrawn from treatment early due to toxicity, but not due to progression. 0For the paclitaxel arm, adverse event review on days other than day 1 of each cycle may be carried out by nurse administering chemotherapy or by phone call if patient not attending clinic.

  • ***Follow-up of any IMP toxicity requiring the participant to be withdrawn from treatment.

  • †††On treatment days to be taken before dosing. Baseline bloods to be taken any time post-randomisation and before treatment on C1D1.

  • ‡‡‡Cycle 6 D1 and cycle 9 D1, cycle 12 D1, etc.

  • BP, blood pressure; ECHO, echocardiography; ECOG, Eastern Cooperative Oncology Group; HCG, human chorionic gonadotropin; INR, international normalised ratio; LVEF, left ventricular ejection eraction; PO, per oral; PTT, partial thromboplastin time; T4, thyroxine; TSH, thyroid stimulating hormone; WBC, white blood cells.