Tenofovir (all routes except local)

Nervous system anomalies

R analysis
id Study   Lib. in paper Exposition period    Study type 
 Control type 
 
Tags OR 95%CI x1/n1 x0/n0 no cases no exposed ROB Ref.
S5131
R13356		 Fowler, 2016 Central Nervous System malformations 2nd and/or 3rd trimester excluded randomized controlled trial exposed to other treatment, sick Adjustment: Randomisation Control group: zidovudine/lamivudine/lopinavir–ritonavir Exposed group: TDF/emtricitabine/lopinavir–ritonavir Indication: HIV 1.03 [0.06;16.46] C
excluded (exposition period) 		1/320   1/328 2 320
ref
S5128
R13327		 Sibiude, 2014 Central Nervous System birth defects (MACDP classification) 1st trimester prospective cohort exposed to other treatment, sick Adjustment: No Control group: non-TDF (mix or unspecified regimens) Exposed group: TDF (mix or unspecified regimens) Indication: HIV 1.27 [0.48;3.55] -/823   -/12,043 - 823
ref
S5132
R13364		 Floridia, 2013 Central nervous system malformations 1st trimester prospective cohort unexposed, sick Adjustment: No Control group: Unexposed, sick Exposed group: TDF (mix or unspecified regimens) Indication: HIV 9.80 [0.40;241.80] C 1/173   0/561 1 173
ref
Total 2 studies 1.96 [0.38;10.03] 1 996
x1: number of endpoints among exposed, n1: number of exposed; x0: number of endpoints among non exposed, n0: number of non exposed; C: calculated odds ratio from numbers of events and effectives

Forest plot

StudyTE95% CIn casesn exposedweightROBABCDEF Sibiude, 2014Sibiude, 2014 1.27[0.48; 3.55]-82379%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Floridia, 2013Floridia, 2013 9.80[0.40; 241.80]117321%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (2 studies) I2 = 30% 1.96[0.38; 10.03]19960.520.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.96[0.38; 10.03]199630%NASibiude, 2014 Floridia, 2013 2 case control studiescase control studies 0 Type of controls unexposed, sickunexposed, sick 9.80[0.40; 241.80]1173 -NAFloridia, 2013 1 exposed to other treatment, sickexposed to other treatment, sick 1.27[0.47; 3.45]-823 -NASibiude, 2014 1 Tags Adjustment   - No  - No 1.96[0.38; 10.03]199630%NASibiude, 2014 Floridia, 2013 2 Control group   - non-TDF (mix or unspecified regimens)  - non-TDF (mix or unspecified regimens) 1.27[0.47; 3.45]-823 -NASibiude, 2014 1   - Unexposed, sick  - Unexposed, sick 9.80[0.40; 241.80]1173 -NAFloridia, 2013 1 Exposed group   - TDF (mix or unspecified regimens)  - TDF (mix or unspecified regimens) 1.96[0.38; 10.03]199630%NASibiude, 2014 Floridia, 2013 2 Indication   - HIV  - HIV 1.96[0.38; 10.03]199630%NASibiude, 2014 Floridia, 2013 2 All studiesAll studies 1.96[0.38; 10.03]199630%NASibiude, 2014 Floridia, 2013 20.520.01.0

Publication bias and p-hacking diagnosis

funnel plot

Funnel plot not drawn. Less than 3 points.

Asymetry test p-value = NaN (by Egger's regression)

not enought points

p values plot

Funnel plot not drawn. Less than 3 points.

Sub-groups analysis using all included studies

excluded

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed, sick controlsunexposed, sick controls 9.80[0.40; 241.80]1173 -NAFloridia, 2013 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.27[0.47; 3.45]-823 -NASibiude, 2014 10.510.01.0